510(k) · Cleared
ClearedChemtrak Accumeter Cholesterol Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtrak, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Mar 19, 1991 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 19, 1991
- Review
- 106 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK905405 Chemtrak Accumeter Cholesterol TestChemtrak, Inc. · 1991
- Descendant · cites it directly · 1 of its ownK960377 Ena-C-T Total Cholesterol TestActimed Laboratories, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK981181 Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK960378 Ena-C-T Assayed Total Cholesterol ControlsActimed Laboratories, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K960377Ena-C-T Total Cholesterol TestActimed Laboratories, Inc. · 1996 · cites it directly1descendant
- K981181Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc. · 1998 · cites it directly0descendants
- K960378Ena-C-T Assayed Total Cholesterol ControlsActimed Laboratories, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905405 | Chemtrak Accumeter Cholesterol Test | Chemtrak, Inc. | 1991 | — |
| +1 | K960377 | Ena-C-T Total Cholesterol Test | Actimed Laboratories, Inc. | 1996 | — |
| +1 | K981181 | Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use) | Actimed Laboratories, Inc. | 1998 | — |
| +1 | K960378 | Ena-C-T Assayed Total Cholesterol Controls | Actimed Laboratories, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K960377 (Actimed Laboratories, Inc., 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K905405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905405: Chemtrak Accumeter Cholesterol Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905405
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026